Multi Vitamin And Fluoride Solution/ Drops

Multi Vitamin And Fluoride Solution/ Drops

Multi Vitamin And Fluoride Solution/ Drops Recall

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Questions & Answers

Side Effects & Adverse Reactions

As in the case of all medications, keep out of reach of children.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Supplementation of the diet with nine essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.
The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Multivitamin and Fluoride Supplemental Drops 0.25 mg provide fluoride in drop form for infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3-6 years, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus nine essential vitamins.

The American Academy of Pediatrics recommended that infants and young children 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and children 3-6, years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a full dose (1mL) of Multi Vitamin and Fluoride Supplemental Drops 0.25 mg. A half dose (0.5mL) of Multi Vitamin and Fluoride Supplemental Drops 0.5 mg could also provide a daily fluoride intake of 0.25mg; however, the dosage reduces vitamin supplementation by half.

Multi Vitamin and Fluoride Supplemental Drops 0.25 mg and Multi Vitamin and Fluoride Supplemental Drops 0.5 mg drops supply significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, infants and children obtain nine essential vitamins and fluoride.

A comprehensive 5-1/2 year series of studies of the effectiveness of multivitamin, iron, and fluoride drops in caries protection has been published. Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided into 2 groups, one which used only the non-fluoride vitamin product, and the other, multi-vitamins-fluoride products. Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided into 2 groups, one which used only non-fluoridated vitamin product and the other, multi-vitamins-fluoride products.

The three-year interim report showed 63% fewer carious surfaces in primary teeth and 43% fewer carious surfaces in permanent teeth of the children taking multi-vitamin-fluoride products.

After four years, the studies continued to support the effectiveness of multi-vitamin-fluoride products, showing a reduction in carious surfaces of 68% in primary teeth and 46% in permanent teeth.

Results at the end of the 51/2 years further confirmed the previous findings and indicated that significant reductions in dental caries are apparent with the continued use of multi-vitamin-fluoride products.

History

There is currently no drug history available for this drug.

Other Information

*
U.S. RDA not established
Each 1.0 mL supplies:Percentage of U.S. Recommended Daily Allowance
InfantsChildren Under 4
Vitamin A1500 IU10060
Vitamin C35 mg10088
Vitamin D400 IU100100
Vitamin E5 IU10050
Thiamine0.5 mg10071
Riboflavin0.6 mg10075
Niacin8 mg10089
Vitamin B60.4 mg10057
Vitamin B122 mcg10067
Fluoride0.25 mg**

This product does not contain the essential vitamin folic acid.

See INDICATIONS AND USAGE section below for use by infants and young children 6 months to 3 years of age.

Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

Other Ingredients: Ascorbic acid, caramel color, cholecalciferol, citric acid, cyanocobalamin, D-alpha tocopheryl acid succinate, ferrous sulfate, flavor, glycerin, methylparaben, niacinamide, polysorbate 80, purified water, pyridoxine HCL, riboflavin-5-phosphate sodium, sodium benzoate, sodium hydroxide, sucralose, thiamine HCL, vitamin A palmitate.

Multi Vitamin And Fluoride Solution/ Drops Manufacturers


  • Libertas Pharma, Inc.
    Multi Vitamin And Fluoride Solution/ Drops [Libertas Pharma, Inc.]

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